study to evaluate the efficacy and safety of colchicine tablets in patients with covid-19

Conditions: Covid19; Colchicine

Summary: this study is designed for single-center, randomized, open label, standard therapy controlled. 60 covid-19 subjects with a treatment period of 10 days and follow-up until 28 days after enrollment.


Eligibility criteria:
inclusion criteria: 1. at the time of signing icf, the subjects were 18 to 65 years old (including 18 and 65 years old), both men and women; 2. within 72 hours before screening, any samples confirmed by the laboratory were positive for sars-cov-2; 3. clinical classification was ordinary type according to the novel coronavirus pneumonia diagnosis and treatment plan (trial 8th edition)； 4. symptoms appeared ≤ 5 days before randomization; such as fever, cough, shortness of breath, sore throat and diarrhea; 5. subjects were able to communicate well with the investigator, and understand and comply with the requirements of this study, understand and sign the icf. exclusion criteria: 1. severe type patients who comply with any of the following： * shortness of breath, rr ≥ 30 times/min; * in the resting state, the oxygen saturation is less than or equal to 93%; * arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × \[760/atmospheric pressure (mmhg)\]; * pulmonary imaging shows that patients with obvious lesion progression \> 50% within 24-48 hours. 2. critical type patients who comply with any of the following： * respiratory failure occurs and mechanical ventilation is required; * shock; * icu monitoring and treatment are required for other organ failure. 3. people who are known to be allergic to the test drug and its components; 4. people with inflammatory bowel disease, chronic diarrhea, malabsorption; 5. people with previous neuromuscular disease; 6. people with severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73m2); 7. people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; 8. patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); 9. people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; 10. people who test positive for anti-sars-cov-2 immunoglobulin g (igg); 11. people who have been vaccinated against covid-19; 12. any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; 13. suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); 14. suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; 15. pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; 16. people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; 17. participated in other clinical studies within 30 days before screening; 18. people who have other factors that the researcher believes are not suitable for inclusion.

Keywords: covid-19 colchicine tablets iit study